Vocational Education and Training (VET)

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1 Vocational Education and Training (VET) 1

2 VET is designed to deliver workplace-specific skills and knowledge that have been determined in consultation with industry

3 In VET, individuals are considered competent when they are able to consistently apply the required knowledge and skills to the standard of performance required in the workplace.

4 Designing competency based training 1. Determine the pitch (level) of the training 2. Determine the essential outcomes of the training (Elements) 3. Determine the knowledge and skills required for each outcome (Performance Criteria) 4. Determine how student will demonstrate that they are capable of applying the knowledge/skills (competency based assessment)

5 Competency based assessment The process of collecting evidence and making judgements on whether competence has been achieved. Confirms that an individual can perform to the standard expected in the workplace.

6 How do we know if an individual is competent? We know whether an individual is competent after they have completed an assessment that verifies that all aspects of the unit of competency are held and can be applied in an industry context. i.e. that they are capable of applying the task Just as learner drivers must demonstrate that they can drive a car by actually taking the examiner for a drive, so too must students demonstrate competence by undergoing an assessment process.

7 - Diploma

8 , Associate Degree

9 - Bachelor Degree

10 , Grad Cert, Grad Dip

11 - Masters

12 Types of assessment methods

13 10562NAT Course in Clinical Trials Application Preparation, Submission and Review 1. CTSENV601A Research Australian clinical trial environment to inform practice 2. CTSDES601A Prepare and submit a clinical trial application 3. CTSREV601A Review clinical trial submissions for authorisation

14 CTSENV601A Research Australian clinical trial environment to inform practice Unit Descriptor This unit describes the skills and knowledge required to apply current and relevant legislative, regulatory, ethical and organisational requirements, systems and processes of the Australian clinical trials environment, including roles and responsibilities of personnel involved in the application preparation, submission, review and authorisation stage, to the preparation of clinical trial protocols, ethics applications and assessment forms for authorisation to conduct clinical trials in Australia. No licensing, legislative, regulatory or certification requirements apply to this unit at the time of publication. Application of the Unit This unit supports the work of personnel responsible for the preparation of high quality clinical trial applications and the assessment of documentation to facilitate timely authorisation of clinical trial projects. Practitioners must be well versed in current and relevant legislative, regulatory, ethical and organisational requirements as well as good practice systems and processes in order to prepare submissions that provide for rigorous and effective research governance during project implementation.

15 ELEMENT Elements describe the essential outcomes of a unit of competency. 1. Explore clinical trial practice in Australia PERFORMANCE CRITERIA Performance criteria describe the required performance needed to demonstrate achievement of the element. Where bold italicised text is used, further information is detailed in the required skills and knowledge and/or the range statement. Assessment of performance is to be consistent with the evidence guide. 1.1 The process of the development, regulation and approval of drugs, devices and therapeutic interventions for humans through clinical trials is examined 1.2 Differences and similarities between clinical trial types and phases are described 1.3 The historical basis for the development of clinical trial research values, principles and regulations is researched 1.4 Models, theories and scholarly debates on clinical trials processes and procedures are researched and critically analysed for application to practice 1.5 Body of theory about Australia s role in the international clinical trial environment is identified and critically analysed for emerging trends and practices 1.6 Key features of research governance and clinical trial authorisation are identified and critically analysed for good practice

16 Assessment strategies for the course Sophie Mepham PhD Senior Manager, Translation and Clinical Research Peter MacCallum Cancer Centre

17 Beth Akister Project Manager/Researcher/Facilitator Department of Health, Science, Education and Social Services Swinburne University of Technology Ph:

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